Senior Clinical Research Coordinator

Position Summary:

We have an exciting opportunity to join our team as a Senior Clinical Research Coordinator. The Senior Clinical Research Coordinator (Senior CRC) serves as a senior research coordinator for the Eosinophilic Gastrointestinal Diseases (EGID) Program at NYU, directed by Mirna Chehade, MD, MPH, and is responsible for the day‑to‑day execution and coordination of a diverse clinical research portfolio focused exclusively on EGIDs.

The portfolio includes industry‑sponsored, government‑funded, investigator‑initiated, foundation‑supported, and unfunded studies across multiple designs, including retrospective, prospective, survey‑based, interventional, and translational and biomarker‑based research.

This is a highly autonomous role designed for an experienced coordinator who can manage competing priorities, identify operational challenges, and drive studies forward with a high degree of independence. Many studies will not have CRO infrastructure or dedicated management support, so the Senior CRC must function as the primary coordinator responsible for study operations, ensuring studies remain compliant, organized, and on track from startup through closeout.

The ideal candidate will be capable of identifying priorities, resolving operational barriers, and advancing studies efficiently in a fast‑paced academic environment. This role is best suited for a research professional with broad experience across academic and sponsor environments, strong regulatory knowledge, excellent attention to detail, and the ambition to grow long‑term within clinical research. It offers the opportunity to help shape and grow a multidisciplinary EGID research program within academic medicine.

• Independently manage a portfolio of EGID studies across multiple funding sources, phases, and methodologies from startup through closeout.
• Prioritize daily, weekly, and long‑term workload across multiple active studies.
• Develop and maintain study timelines, milestone trackers, enrollment trackers, and operational workflows.
• Identify barriers to execution, operational risks, and proactively communicate issues and solutions to the PI and appropriate stakeholders.
• Serve as the primary operational point of contact for investigators, sponsors, CROs, collaborators, and internal departments.
• Provide study status updates to the PI and leadership regarding progress, risks, timelines, and resource needs as requested.
• Prepare and manage all IRB submissions, including initial applications, amendments, continuing reviews, reportable events, deviations, closures, and recruitment materials.
• Maintain accurate, complete, and inspection‑ready regulatory files and track approvals, expirations, and required submissions.
• Ensure studies are conducted in compliance with protocol requirements, GCP, institutional policy, and applicable regulations.
• Participate in sponsor meetings, feasibility assessments, monitor visits, and study startup discussions as appropriate.
• Independently lead participant recruitment through chart review, database screening, outreach, provider networking, and other strategic methods.
• Work with internal and external resources to design, improve, and execute recruitment plans for rare disease and specialty populations.
• Conduct eligibility screening and enroll qualified participants efficiently.
• Obtain informed consent and assent for adult and pediatric participants, including complex and interventional studies involving families and special populations.
• Build strong participant and family relationships to support retention and long‑term engagement.
• Coordinate and conduct research visits across outpatient, procedural, laboratory, and remote settings.
• Manage all visit logistics with participants and relevant departments, including scheduling, room readiness, supplies, protocol procedures, and required resources.
• Prepare visit packets, worksheets, CRFs, questionnaires, specimen kits, and source documents.
• Ensure protocol windows, follow‑up schedules, and visit requirements are met.
• Collect, organize, and maintain complete source documentation for PI review and signature.
• Perform accurate and timely data entry in sponsor EDC…